1 132 124 A PRAGMATIC MULTICENTERED RANDOMIZED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: ECONOMIC EVALUATION. STUDY DESIGN: MULTICENTERED RANDOMIZED CONTROLLED TRIAL WITH QUALITY OF LIFE AND RESOURCE USE DATA COLLECTED. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE COST-EFFECTIVENESS OF YOGA INTERVENTION PLUS USUAL CARE COMPARED WITH USUAL CARE ALONE FOR CHRONIC OR RECURRENT LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: YOGA HAS BEEN SHOWN AS AN EFFECTIVE INTERVENTION FOR TREATING CHRONIC OR RECURRENT LOW BACK PAIN. HOWEVER, THERE IS LITTLE EVIDENCE ON ITS COST-EFFECTIVENESS. THE DATA ARE EXTRACTED FROM A PRAGMATIC, MULTICENTERED, RANDOMIZED CONTROLLED TRIAL THAT HAS BEEN CONDUCTED TO EVALUATE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF A 12-WEEK PROGRESSIVE PROGRAM OF YOGA PLUS USUAL CARE IN PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. METHODS: WITH THIS TRIAL DATA, A COST-EFFECTIVENESS ANALYSIS DURING THE TIME PERIOD OF 12 MONTHS FROM BOTH PERSPECTIVES OF THE UK NATIONAL HEALTH SERVICE AND THE SOCIETAL IS PRESENTED. MAIN OUTCOME MEASURE IS AN INCREMENTAL COST PER QUALITY-ADJUSTED LIFE-YEAR (QALY). RESULTS: FROM THE PERSPECTIVE OF THE U.K. NATIONAL HEALTH SERVICE, YOGA INTERVENTION YIELDS AN INCREMENTAL COST-EFFECTIVENESS RATIO OF POUND13,606 PER QALY. GIVEN A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000, THE PROBABILITY OF YOGA INTERVENTION BEING COST-EFFECTIVE IS 72%. FROM THE PERSPECTIVE OF THE SOCIETY, YOGA INTERVENTION IS A DOMINANT TREATMENT COMPARED WITH USUAL CARE ALONE. THIS RESULT IS SURROUNDED BY FEWER UNCERTAINTIES-THE PROBABILITY OF YOGA BEING COST-EFFECTIVE REACHES 95% AT A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000. SENSITIVE ANALYSES SUGGEST THE SAME RESULTS THAT YOGA INTERVENTION IS LIKELY TO BE COST-EFFECTIVE IN BOTH PERSPECTIVES. CONCLUSION: ON THE BASIS OF THIS TRIAL, 12 WEEKLY GROUP CLASSES OF SPECIALIZED YOGA ARE LIKELY TO BE A COST-EFFECTIVE INTERVENTION FOR TREATING PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. 2012 2 2843 38 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS. 2021 3 556 56 COST-EFFECTIVENESS OF EARLY INTERVENTIONS FOR NON-SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED STUDY INVESTIGATING MEDICAL YOGA, EXERCISE THERAPY AND SELF-CARE ADVICE. OBJECTIVE: TO EVALUATE THE COST-EFFECTIVENESS OF MEDICAL YOGA AS AN EARLY INTERVENTION COMPARED WITH EVIDENCE-BASED EXERCISE THERAPY AND SELF-CARE ADVICE FOR NON-SPECIFIC LOW BACK PAIN. DESIGN: RANDOMIZED CONTROLLED TRIAL WITH A COST-EFFECTIVENESS ANALYSIS. SUBJECTS: A TOTAL OF 159 PARTICIPANTS RANDOMIZED INTO THE MEDICAL YOGA GROUP (N = 52), THE EXERCISE THERAPY GROUP (N = 52) AND THE SELF-CARE ADVICE GROUP (N = 55). METHODS: THE HEALTH OUTCOME MEASURE EQ-5D WAS APPLIED TO MEASURE QUALITY OF LIFE DATA COMBINED WITH COST DATA COLLECTED FROM TREATMENT GROUPS FROM BASELINE TO 12 MONTHS FOLLOW-UP. OUTCOME MEASURE WAS HEALTH-RELATED QUALITY OF LIFE (HRQL). INCREMENTAL COST PER QUALITY ADJUSTED LIFE YEAR (QALY) WAS ALSO CALCULATED. COST-EFFECTIVENESS ANALYSIS WAS CONDUCTED PRIMARILY FROM THE SOCIETAL AND EMPLOYER PERSPECTIVES. RESULTS: MEDICAL YOGA IS COST-EFFECTIVE COMPARED WITH SELF-CARE ADVICE IF AN EMPLOYER CONSIDERS THE SIGNIFICANT IMPROVEMENT IN THE HRQL OF AN EMPLOYEE WITH LOW BACK PAIN JUSTIFIES THE ADDITIONAL COST OF TREATMENT (I.E. IN THIS STUDY EUR 150). FROM A SOCIETAL PERSPECTIVE, MEDICAL YOGA IS A COST-EFFECTIVE TREATMENT COMPARED WITH EXERCISE THERAPY AND SELF-CARE ADVICE IF AN ADDITIONAL QALY IS WORTH EUR 11,500. SENSITIVITY ANALYSIS SUGGESTS THAT MEDICAL YOGA IS MORE COST-EFFECTIVE THAN ITS ALTERNATIVES. CONCLUSION: SIX WEEKS OF UNINTERRUPTED MEDICAL YOGA THERA-PY IS A COST-EFFECTIVE EARLY INTERVENTION FOR NON-SPECIFIC LOW BACK PAIN, WHEN TREATMENT RECOMMENDATIONS ARE ADHERED TO. 2015 4 2831 44 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014 5 2408 37 YOGA AND HEALTHCARE IN THE UNITED KINGDOM. THE EMERGENCE OF YOGA THERAPY IN THE UNITED KINGDOM BEGAN ABOUT 45 YEARS AGO WITH THE EMERGENCE OF YOGA THERAPY ORGANIZATIONS THAT OFFERED BOTH TREATMENT AND TRAINING. THE INTEGRATION OF YOGA INTO THE NATIONAL HEALTH SERVICE (NHS) IS GRADUALLY HAPPENING BECAUSE: (A) YOGA RESEARCH SUPPORTS ITS EFFICACY AS A COST-EFFECTIVE, PREVENTIVE AND COMPLEMENTARY TREATMENT FOR A HOST OF NON-COMMUNICABLE DISEASES; AND (B) THE ESCALATING ECONOMIC BURDEN OF LONG-TERM CONDITIONS IS OVERWHELMING THE NHS. THE NHS IS ACTIVELY DEVELOPING 'SUSTAINABILITY AND TRANSFORMATION PLANS' THAT INCLUDE YOGA. CHIEF AMONG THESE IS 'SOCIAL PRESCRIBING,' WHICH EMPOWERS PATIENTS WITH COMPLEX HEALTH NEEDS THROUGH ACTIVITIES GROUPS. THESE ACTIVITIES REDUCE SEDENTARY HABITS AND SOCIAL ISOLATION, WHILE HELPING PATIENTS TO BE MORE SELF-RELIANT. THE NHS HAS ALLOCATED POUND450 MILLION IN FUNDING TO IMPLEMENT A VARIETY OF PROGRAMS FOR ITS OWN STAFF, IN WHICH STAFF YOGA CLASSES WERE EXPRESSLY MENTIONED. THE YOGA COMMUNITY IS MOBILIZING FORCES AND APPLYING FOR FUNDING TO PILOT RELEVANT NHS STAFF YOGA COURSES THAT CAN SUPPORT THE SERVICE IN ACHIEVING ITS VISION. RESEARCH SHOWS THAT INTEGRATING YOGA THERAPY FOR THE TREATMENT OF LOW BACK PAIN (LBP) INTO THE NHS WOULD RESULT IN SIGNIFICANT COST SAVINGS AS COMPARED WITH USUAL CARE. THE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE) GUIDELINES ON LBP AND SCIATICA INCLUDE YOGA AS ONE OF THE RECOMMENDED TREATMENTS FOR THESE CONDITIONS. THREE GROUPS OF YOGA TEACHERS, USING DIFFERENT YOGA PRACTICES, HAVE GAINED TRACTION WITH THE NHS FOR THE APPLICATION OF YOGA THERAPY TO LBP. MANY REGIONAL HOSPITALS IN ENGLAND HAVE YOGA CLASSES. THE NHS CHOICES WEBSITE, WHICH CONVEYS INFORMATION TO THE PUBLIC REGARDING TREATMENT OPTIONS, HAS A PAGE DEDICATED TO THE HEALTH BENEFITS OF YOGA. SEVERAL INSTITUTIONS OFFER COMPREHENSIVE TRAINING PROGRAMS IN YOGA THERAPY AND YOGA THERAPY IS RECOGNIZED AS AN OFFICIAL PROFESSION. THE YOGA IN HEALTHCARE ALLIANCE HAS BEEN ESTABLISHED TO HELP INTEGRATE YOGA THERAPY INTO THE NHS. THIS CONSISTS OF PARLIAMENTARIANS, LEADERS IN THE NHS, YOGA RESEARCHERS, HEALTH PROFESSIONALS, AND REPRESENTATIVES FROM LEADING YOGA ORGANIZATIONS. 2017 6 557 62 COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN IN VETERANS. BACKGROUND: YOGA INTERVENTIONS CAN IMPROVE FUNCTION AND REDUCE PAIN IN PERSONS WITH CHRONIC LOW BACK PAIN (CLBP). OBJECTIVE: USING DATA FROM A RECENT TRIAL OF YOGA FOR MILITARY VETERANS WITH CLBP, WE ANALYZED THE INCREMENTAL COST-EFFECTIVENESS OF YOGA COMPARED WITH USUAL CARE. METHODS: PARTICIPANTS (N=150) WERE RANDOMIZED TO EITHER 2X WEEKLY, 60-MINUTE YOGA SESSIONS FOR 12 WEEKS, OR TO DELAYED TREATMENT (DT). OUTCOMES WERE MEASURED AT 12 WEEKS, AND 6 MONTHS. QUALITY-ADJUSTED LIFE YEARS (QALYS) WERE MEASURED USING THE EQ-5D SCALE. A 30% IMPROVEMENT ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (PRIMARY OUTCOME) SERVED AS AN ADDITIONAL EFFECTIVENESS MEASURE. INTERVENTION COSTS INCLUDING PERSONNEL, MATERIALS, AND TRANSPORTATION WERE TRACKED DURING THE STUDY. HEALTH CARE COSTS WERE OBTAINED FROM PATIENT MEDICAL RECORDS. HEALTH CARE ORGANIZATION AND SOCIETAL PERSPECTIVES WERE EXAMINED WITH A 12-MONTH HORIZON. RESULTS: INCREMENTAL QALYS GAINED BY THE YOGA GROUP OVER 12 MONTHS WERE 0.043. INTERVENTION COSTS TO DELIVER YOGA WERE $307/PARTICIPANT. NEGLIGIBLE DIFFERENCES IN HEALTH CARE COSTS WERE FOUND BETWEEN GROUPS. FROM THE HEALTH CARE ORGANIZATION PERSPECTIVE, THE INCREMENTAL COST-EFFECTIVENESS RATIO TO PROVIDE YOGA WAS $4488/QALY. FROM THE SOCIETAL PERSPECTIVE, YOGA WAS "DOMINANT" PROVIDING BOTH HEALTH BENEFIT AND COST SAVINGS. PROBABILISTIC SENSITIVITY ANALYSIS INDICATES AN 89% CHANCE OF YOGA BEING COST-EFFECTIVE AT A WILLINGNESS-TO-PAY OF $50,000. A SCENARIO COMPARING THE COSTS OF YOGA AND PHYSICAL THERAPY SUGGEST THAT YOGA MAY PRODUCE SIMILAR RESULTS AT A MUCH LOWER COST. DISCUSSION/CONCLUSIONS: YOGA IS A COST-EFFECTIVE TREATMENT FOR REDUCING PAIN AND DISABILITY AMONG MILITARY VETERANS WITH CLBP. 2020 7 558 56 COST-EFFECTIVENESS OF YOGA FOR MANAGING MUSCULOSKELETAL CONDITIONS IN THE WORKPLACE. BACKGROUND: BACK PAIN AND MUSCULOSKELETAL CONDITIONS NEGATIVELY AFFECT THE HEALTH-RELATED QUALITY OF LIFE (HRQL) OF EMPLOYEES AND GENERATE SUBSTANTIAL COSTS TO EMPLOYERS. AIMS: TO ASSESS THE COST-EFFECTIVENESS OF YOGA FOR MANAGING MUSCULOSKELETAL CONDITIONS. METHODS: A RANDOMIZED CONTROLLED TRIAL EVALUATED AN 8-WEEK YOGA PROGRAMME, WITH A 6-MONTH FOLLOW-UP, FOR NATIONAL HEALTH SERVICE (NHS) EMPLOYEES. EFFECTIVENESS IN MANAGING MUSCULOSKELETAL CONDITIONS WAS ASSESSED USING REPEATED-MEASURES GENERALIZED LINEAR MODELLING FOR THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RDQ) AND THE KEELE START BACK SCREENING TOOL. COST-EFFECTIVENESS WAS DETERMINED USING AREA-UNDER-THE-CURVE LINEAR REGRESSION FOR ASSESSING HRQL FROM HEALTHCARE AND SOCIETAL PERSPECTIVES. THE INCREMENTAL COST PER QUALITY-ADJUSTED LIFE YEAR (QALY) WAS ALSO CALCULATED. SICKNESS ABSENCE WAS MEASURED USING ELECTRONIC STAFF RECORDS AT 6 MONTHS. RESULTS: THERE WERE 151 PARTICIPANTS. AT 6 MONTHS, MEAN DIFFERENCES BETWEEN GROUPS FAVOURING YOGA WERE OBSERVED FOR RDQ [-0.63 (95% CI, -1.78, 0.48)], KEELE START [-0.28 (95% CI, -0.97, 0.07)] AND HRQL (0.016 QALY GAIN). FROM A HEALTHCARE PERSPECTIVE, YOGA YIELDED AN INCREMENTAL COST-EFFECTIVENESS RATIO OF POUND2103 PER QALY. GIVEN A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20 000, THE PROBABILITY OF YOGA BEING COST-EFFECTIVE WAS 95%. FROM A SOCIETAL PERSPECTIVE, YOGA WAS THE DOMINANT TREATMENT COMPARED WITH USUAL CARE. AT 6 MONTHS, ELECTRONIC STAFF RECORDS SHOWED THAT YOGA PARTICIPANTS MISSED A TOTAL OF 2 WORKING DAYS DUE TO MUSCULOSKELETAL CONDITIONS COMPARED WITH 43 DAYS FOR USUAL CARE PARTICIPANTS. CONCLUSIONS: YOGA FOR NHS EMPLOYEES MAY ENHANCE HRQL, REDUCE DISABILITY ASSOCIATED WITH BACK PAIN, LOWER SICKNESS ABSENCE DUE TO MUSCULOSKELETAL CONDITIONS AND IS LIKELY TO BE COST-EFFECTIVE. 2017 8 2638 47 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 9 2598 49 YOGA FOR OLDER ADULTS WITH MULTIMORBIDITY (THE GENTLE YEARS YOGA TRIAL): STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL. BACKGROUND: MULTIMORBIDITY IS COMMON IN OLDER ADULTS AND ASSOCIATED WITH HIGH LEVELS OF ILLNESS BURDEN AND HEALTHCARE EXPENDITURE. THE EVIDENCE BASE FOR HOW TO MANAGE OLDER ADULTS WITH MULTIMORBIDITY IS WEAK. YOGA MIGHT BE A USEFUL INTERVENTION BECAUSE IT HAS THE POTENTIAL TO IMPROVE HEALTH-RELATED QUALITY OF LIFE, PHYSICAL FUNCTIONING, AND SEVERAL MEDICAL CONDITIONS. THE BRITISH WHEEL OF YOGA'S GENTLE YEARS YOGA(C) (GYY) PROGRAMME WAS DEVELOPED SPECIFICALLY FOR OLDER ADULTS, INCLUDING THOSE WITH CHRONIC MEDICAL CONDITIONS. DATA FROM A PILOT TRIAL SUGGESTED FEASIBILITY OF USING GYY IN THIS POPULATION, BUT ITS EFFECTIVENESS AND COST-EFFECTIVENESS REMAIN UNCERTAIN. METHODS: THIS IS A MULTI-SITE, INDIVIDUALLY RANDOMISED, SUPERIORITY TRIAL WITH AN EMBEDDED PROCESS EVALUATION AND AN ECONOMIC ANALYSIS OF COST-EFFECTIVENESS. THE TRIAL WILL COMPARE AN EXPERIMENTAL STRATEGY OF OFFERING A 12-WEEK GYY PROGRAMME AGAINST A CONTROL STRATEGY OF NO OFFER IN COMMUNITY-DWELLING ADULTS AGED 65 OR OVER WHO HAVE MULTIMORBIDITY, DEFINED AS HAVING TWO OR MORE CHRONIC CONDITIONS FROM A PREDEFINED LIST. THE PRIMARY OUTCOME IS HEALTH-RELATED QUALITY OF LIFE MEASURED USING THE EQ-5D-5L, THE PRIMARY ENDPOINT BEING THE OVERALL DIFFERENCE OVER 12 MONTHS. BOTH GROUPS WILL CONTINUE TO BE ABLE TO ACCESS THEIR USUAL CARE FROM PRIMARY, SECONDARY, COMMUNITY, AND SOCIAL SERVICES. PARTICIPANTS, CARE PROVIDERS, AND YOGA TEACHERS WILL NOT BE BLINDED TO THE ALLOCATED INTERVENTION. OUTCOME MEASURES ARE PRIMARILY SELF-REPORTED. THE ANALYSIS WILL FOLLOW INTENTION-TO-TREAT PRINCIPLES. DISCUSSION: THIS PRAGMATIC RANDOMISED CONTROLLED TRIAL WILL DEMONSTRATE IF THE GYY PROGRAMME IS AN EFFECTIVE, COST-EFFECTIVE, AND VIABLE ADDITION TO THE MANAGEMENT OF OLDER ADULTS WITH MULTIMORBIDITY. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . REGISTERED ON 18 MARCH 2019. 2021 10 2824 50 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183. 2016 11 131 41 A PRAGMATIC MULTI-CENTRED RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: TRIAL PROTOCOL. UNLABELLED: A SYSTEMATIC REVIEW REVEALED THREE SMALL RANDOMISED CONTROLLED TRIALS OF YOGA FOR LOW BACK PAIN, ALL OF WHICH SHOWED EFFECTS ON BACK PAIN THAT FAVOURED THE YOGA GROUP. TO BUILD ON THESE STUDIES A LARGER TRIAL, WITH LONGER TERM FOLLOW-UP, AND A NUMBER OF DIFFERENT YOGA TEACHERS DELIVERING THE INTERVENTION IS REQUIRED. THIS STUDY PROTOCOL DESCRIBES THE DETAILS OF A RANDOMISED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN, WHICH IS FUNDED BY ARTHRITIS RESEARCH CAMPAIGN (ARC) AND IS BEING CONDUCTED BY THE UNIVERSITY OF YORK. 262 PATIENTS WILL BE RECRUITED FROM GP PRACTICES IN 5 CENTRES IN ENGLAND. PATIENTS WILL BE RANDOMISED TO RECEIVE USUAL CARE OR 12 WEEKLY CLASSES OF YOGA. A YOGA PROGRAMME WILL BE DEVISED THAT CAN BE DELIVERED BY YOGA TEACHERS OF THE TWO MAIN NATIONAL YOGA ORGANISATIONS IN THE UK (BRITISH WHEEL OF YOGA AND IYENGAR YOGA ASSOCIATION (UK)). TRIAL REGISTRATION: CURRENT CONTROLLED TRIALS REGISTRY ISRCTN81079604 (DATE REGISTERED 30/03/2007). 2010 12 2861 40 YOGA-BASED EXERCISE TO PREVENT FALLS IN COMMUNITY-DWELLING PEOPLE AGED 60 YEARS AND OVER: STUDY PROTOCOL FOR THE SUCCESSFUL AGEING (SAGE) YOGA RANDOMISED CONTROLLED TRIAL. INTRODUCTION: FALLS SIGNIFICANTLY REDUCE INDEPENDENCE AND QUALITY OF LIFE IN OLDER AGE. BALANCE-SPECIFIC EXERCISE PREVENTS FALLS IN PEOPLE AGED 60+ YEARS. YOGA IS GROWING IN POPULARITY AND CAN PROVIDE A HIGH CHALLENGE TO BALANCE; HOWEVER, THE EFFECT OF YOGA ON FALLS HAS NOT BEEN EVALUATED. THIS TRIAL AIMS TO ESTABLISH THE EFFECT ON FALLS OF A YOGA EXERCISE PROGRAMME COMPARED WITH A YOGA RELAXATION PROGRAMME IN COMMUNITY-DWELLERS AGED 60+ YEARS. METHOD AND ANALYSIS: THIS RANDOMISED CONTROLLED TRIAL WILL INVOLVE 560 COMMUNITY-DWELLING PEOPLE AGED 60+ YEARS. PARTICIPANTS WILL BE RANDOMISED TO EITHER: (1) THE SUCCESSFUL AGEING (SAGE) YOGA EXERCISE PROGRAMME OR (2) A YOGA RELAXATION PROGRAMME. PRIMARY OUTCOME IS RATE OF FALLS IN THE 12 MONTHS POST RANDOMISATION. SECONDARY OUTCOMES INCLUDE MENTAL WELL-BEING, PHYSICAL ACTIVITY, HEALTH-RELATED QUALITY OF LIFE, BALANCE SELF-CONFIDENCE, PHYSICAL FUNCTION, PAIN, GOAL ATTAINMENT AND SLEEP QUALITY AT 12 MONTHS AFTER RANDOMISATION. THE NUMBER OF FALLS PER PERSON-YEAR WILL BE ANALYSED USING NEGATIVE BINOMIAL REGRESSION MODELS TO ESTIMATE BETWEEN-GROUP DIFFERENCE IN FALL RATES. GENERALISED LINEAR MODELS WILL ASSESS THE EFFECT OF GROUP ALLOCATION ON THE CONTINUOUSLY SCORED SECONDARY OUTCOMES, ADJUSTING FOR BASELINE SCORES. AN ECONOMIC ANALYSIS WILL COMPARE THE COST-EFFECTIVENESS AND COST-UTILITY OF THE TWO YOGA PROGRAMMES. ETHICS AND DISSEMINATION: PROTOCOL WAS APPROVED BY THE HUMAN RESEARCH ETHICS COMMITTEE AT THE UNIVERSITY OF SYDNEY, AUSTRALIA (APPROVAL 2019/604). TRIAL RESULTS WILL BE DISSEMINATED VIA PEER-REVIEWED ARTICLES, CONFERENCE PRESENTATIONS, LAY SUMMARIES. TRIAL REGISTRATION NUMBER: THE PROTOCOL FOR THIS TRIAL IS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ACTRN12619001183178). 2020 13 2035 25 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED. 2018 14 1093 36 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248. 2019 15 921 31 EFFECTIVENESS OF YOGA AS THE PUBLIC HEALTH INTERVENTION MODULE IN THE MANAGEMENT OF DIABETES AND DIABETES ASSOCIATED DEMENTIA IN SOUTH EAST ASIA: A NARRATIVE REVIEW. BACKGROUND: DIABETES MELLITUS (DM) IS WIDELY SPREAD IN SOUTH ASIAN (ASEAN) AND INDIAN SUB-CONTINENT. THE INCREASING HEALTHCARE COSTS OF DM CAN BE PREVENTED IN THE DEVELOPING WORLD BY IMPROVED PUBLIC HEALTHCARE INTERVENTIONS. MODIFIABLE RISK FACTORS OF DM LIKE SEDENTARY LIFESTYLE, OBESITY, AND STRESSFUL CONDITIONS ARE ASSOCIATED WITH ITS PROGRESSION; HOWEVER, THE EPIDEMIOLOGICAL DATA COLLECTED BY PUBLIC INSTITUTIONS ARE LIMITED. SUMMARY: A REVIEW OF PUBLISHED LITERATURE DESCRIBING GEOGRAPHIC DISTRIBUTION OF DM AND ASSOCIATED DEMENTIA IN SOUTH ASIAN REGION, PARTICULARLY INDIA, WAS CONDUCTED WITH THE PURPOSE OF ASSESSING THE FEASIBILITY AND CHALLENGES ASSOCIATED WITH THE YOGA-BASED RISK REDUCTION. PUBMED AND GOOGLE SCHOLAR DATABASES WERE SEARCHED FOR DM AND DEMENTIA-RELATED ARTICLES BY USING A COMBINATION OF KEYWORDS: DIABETES, DIABETES RELATED DEMENTIA SOUTHEAST ASIA, PRE-DIABETES, YOGA, LIFESTYLE MODIFICATION, DEMENTIA AND EXERCISE. THE EPIDEMIOLOGICAL DATA GENERATED FROM THESE DISEASES HAVE NOT PROMPTED TO ANY MAJOR PUBLIC HEALTH POLICIES. YOGA CAN BE A COST-EFFECTIVE INTERVENTION FOR THE PREVENTION OF TYPE 2 DM (T2DM) AND ITS ASSOCIATED COGNITIVE DECLINE WHEN DETECTED EARLY. IF NATIONWIDE INTERVENTION OF YOGA IS BROUGHT ABOUT BY THE STATE, ITS INTEGRATION IN HEALTH CARE WILL BECOME MORE MEANINGFUL AND ACCEPTABLE. KEY MESSAGE: STUDIES SUGGEST THAT YOGA AND CHANGE IN LIFESTYLE CAN MODIFY THE HEALTH RISKS ASSOCIATED WITH T2DM AND ASSOCIATED DEMENTIA IF IT IS MAINSTREAMED WITH THE PUBLIC HEALTH INITIATIVE OF AYUSHMAN BHARAT SCHEME. 2020 16 2732 33 YOGA ON OUR MINDS: A SYSTEMATIC REVIEW OF YOGA FOR NEUROPSYCHIATRIC DISORDERS. BACKGROUND: THE DEMAND FOR CLINICALLY EFFICACIOUS, SAFE, PATIENT ACCEPTABLE, AND COST-EFFECTIVE FORMS OF TREATMENT FOR MENTAL ILLNESS IS GROWING. SEVERAL STUDIES HAVE DEMONSTRATED BENEFIT FROM YOGA IN SPECIFIC PSYCHIATRIC SYMPTOMS AND A GENERAL SENSE OF WELL-BEING. OBJECTIVE: TO SYSTEMATICALLY EXAMINE THE EVIDENCE FOR EFFICACY OF YOGA IN THE TREATMENT OF SELECTED MAJOR PSYCHIATRIC DISORDERS. METHODS: ELECTRONIC SEARCHES OF THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS AND THE STANDARD BIBLIOGRAPHIC DATABASES, MEDLINE, EMBASE, AND PSYCINFO, WERE PERFORMED THROUGH APRIL 2011 AND AN UPDATED IN JUNE 2011 USING THE KEYWORDS YOGA AND PSYCHIATRY OR DEPRESSION OR ANXIETY OR SCHIZOPHRENIA OR COGNITION OR MEMORY OR ATTENTION AND RANDOMIZED CONTROLLED TRIAL (RCT). STUDIES WITH YOGA AS THE INDEPENDENT VARIABLE AND ONE OF THE ABOVE MENTIONED TERMS AS THE DEPENDENT VARIABLE WERE INCLUDED AND EXCLUSION CRITERIA WERE APPLIED. RESULTS: THE SEARCH YIELDED A TOTAL OF 124 TRIALS, OF WHICH 16 MET RIGOROUS CRITERIA FOR THE FINAL REVIEW. GRADE B EVIDENCE SUPPORTING A POTENTIAL ACUTE BENEFIT FOR YOGA EXISTS IN DEPRESSION (FOUR RCTS), AS AN ADJUNCT TO PHARMACOTHERAPY IN SCHIZOPHRENIA (THREE RCTS), IN CHILDREN WITH ADHD (TWO RCTS), AND GRADE C EVIDENCE IN SLEEP COMPLAINTS (THREE RCTS). RCTS IN COGNITIVE DISORDERS AND EATING DISORDERS YIELDED CONFLICTING RESULTS. NO STUDIES LOOKED AT PRIMARY PREVENTION, RELAPSE PREVENTION, OR COMPARATIVE EFFECTIVENESS VERSUS PHARMACOTHERAPY. CONCLUSION: THERE IS EMERGING EVIDENCE FROM RANDOMIZED TRIALS TO SUPPORT POPULAR BELIEFS ABOUT YOGA FOR DEPRESSION, SLEEP DISORDERS, AND AS AN AUGMENTATION THERAPY. LIMITATIONS OF LITERATURE INCLUDE INABILITY TO DO DOUBLE-BLIND STUDIES, MULTIPLICITY OF COMPARISONS WITHIN SMALL STUDIES, AND LACK OF REPLICATION. BIOMARKER AND NEUROIMAGING STUDIES, THOSE COMPARING YOGA WITH STANDARD PHARMACO- AND PSYCHOTHERAPIES, AND STUDIES OF LONG-TERM EFFICACY ARE NEEDED TO FULLY TRANSLATE THE PROMISE OF YOGA FOR ENHANCING MENTAL HEALTH. 2012 17 2927 38 [YOGA FOR MENTAL DISORDERS]. BACKGROUND: THE DEMAND FOR COMPLEMENTARY CLINICALLY EFFICACIOUS, SAFE, PATIENT ACCEPTABLE, AND COST-EFFECTIVE FORMS OF TREATMENT FOR MENTAL ILLNESS IS GROWING. YOGA HAS BENEFICIAL EFFECTS ON SOMATIC AND MENTAL HEALTH FACTORS; THEREFORE, YOGA HAS PREVENTIVE AND THERAPEUTIC CAPABILITIES TO IMPROVE MENTAL DYSFUNCTION. OBJECTIVE: IN THIS OVERVIEW OF THE CURRENT LITERATURE, THE EVIDENCE OF THE EFFECTS OF YOGA ON SELECTED MAJOR PSYCHIATRIC DISORDERS IS SUMMARIZED. RESULTS: THE STRONGEST EVIDENCE BASE FOR YOGA EXISTS IN REDUCING DEPRESSIVE SYMPTOMS BUT ITS USE IN MAJOR DEPRESSIVE DISORDERS IS LESS CLEAR. THE EVIDENCE FOR THE EFFICACY OF YOGA FOR ANXIETY DISORDERS, AND POSTTRAUMATIC STRESS DISORDER (PTSD) IS ENCOURAGING, BUT NOT DEFINITIVE DUE TO ONLY A FEW RANDOMIZED CONTROLLED TRIALS AND METHODOLOGICAL PROBLEMS. CONCLUSION: THERE IS PRELIMINARY EVIDENCE THAT MEDITATION-BASED YOGA INTERVENTIONS MAY BE HELPFUL FOR DEPRESSION, ANXIETY AND PTSD; HOWEVER, THERE MAY ALSO BE THE RISK OF ENGAGING IN EXTREME YOGA PRACTICES. THE VALUE OF INTEGRATING YOGA INTO A TREATMENT PLAN FOR PATIENTS WITH PSYCHIATRIC DISORDERS NEEDS TO BE EVALUATED ON AN INDIVIDUAL BASIS. HEALTHCARE PROVIDERS CAN MOTIVATE AND HELP PATIENTS EVALUATE WHETHER A GIVEN YOGA CLASS IS HELPFUL AND SAFE FOR THEM. METHODOLOGICAL PROBLEMS AND THE UNCLEAR RISK-BENEFIT RATIO PRECLUDE DEFINITIVE RECOMMENDATIONS FOR YOGA AS AN ADJUNCT TREATMENT. 2018 18 536 48 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY. 2010 19 900 45 EFFECTIVENESS AND COST-EFFECTIVENESS OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAM FOLLOWING ACUTE MYOCARDIAL INFARCTION: STUDY RATIONALE AND DESIGN OF A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CARDIAC REHABILITATION (CR) IS A STANDARD TREATMENT FOR SECONDARY PREVENTION OF ACUTE MYOCARDIAL INFARCTION (AMI) IN HIGH INCOME COUNTRIES (HICS), BUT IT IS INACCESSIBLE TO MOST PATIENTS IN INDIA DUE TO HIGH COSTS AND SKILLS REQUIRED FOR MULTIDISCIPLINARY CR TEAMS. WE DEVELOPED A LOW-COST AND SCALABLE CR PROGRAM BASED ON CULTURALLY-ACCEPTABLE PRACTICE OF YOGA (YOGA-CARE). IN THIS PAPER, WE REPORT THE RATIONALE AND DESIGN FOR EVALUATION OF ITS EFFECTIVENESS AND COST-EFFECTIVENESS. METHODS: THIS IS A MULTI-CENTER, SINGLE-BLIND, TWO-ARM PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL ACROSS 22 CARDIAC CARE HOSPITALS IN INDIA. FOUR THOUSAND PATIENTS AGED 18-80YEARS WITH AMI WILL BE RECRUITED AND RANDOMIZED 1:1 TO RECEIVE YOGA-CARE PROGRAM (13 SESSIONS SUPERVISED BY AN INSTRUCTOR AND ENCOURAGEMENT TO SELF-PRACTICE DAILY) OR ENHANCED STANDARD CARE (3 SESSIONS OF HEALTH EDUCATION) DELIVERED OVER A PERIOD OF THREE MONTHS. PARTICIPANTS WILL BE FOLLOWED 3-MONTHLY TILL THE END OF THE TRIAL. THE CO-PRIMARY OUTCOMES ARE A) TIME TO OCCURRENCE OF FIRST CARDIOVASCULAR EVENT (COMPOSITE OF ALL-CAUSE MORTALITY, NON-FATAL MYOCARDIAL INFARCTION, NON-FATAL STROKE AND EMERGENCY CARDIOVASCULAR HOSPITALIZATION), AND B) QUALITY OF LIFE (EURO-QOL-5L) AT 12WEEKS. SECONDARY OUTCOMES INCLUDE NEED FOR REVASCULARIZATION PROCEDURES, RETURN TO PRE-INFARCT ACTIVITIES, TOBACCO CESSATION, MEDICATION ADHERENCE, AND COST-EFFECTIVENESS OF THE INTERVENTION. CONCLUSION: THIS TRIAL WILL ALONE CONTRIBUTE >20% PARTICIPANTS TO EXISTING META-ANALYSES OF RANDOMIZED TRIALS OF CR WORLDWIDE. IF YOGA-CARE IS FOUND TO BE EFFECTIVE, IT HAS THE POTENTIAL TO SAVE MILLIONS OF LIVES AND TRANSFORM CARE OF AMI PATIENTS IN INDIA AND OTHER LOW AND MIDDLE INCOME COUNTRY SETTINGS. 2019 20 319 56 AN INTERVENTION WITH DANCE AND YOGA FOR GIRLS WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS (JUST IN TIME): PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT MANY CHILDREN WORLDWIDE, PREDOMINANTLY GIRLS, AND CAUSE CONSIDERABLE LONG-TERM NEGATIVE CONSEQUENCES FOR INDIVIDUALS AND SOCIETY. EVIDENCE-BASED AND COST-EFFECTIVE TREATMENTS ARE THEREFORE STRONGLY NEEDED. PHYSICAL ACTIVITY HAS SHOWN PROMISING EFFECTS IN THE PRACTICAL MANAGEMENT OF FAPDS. DANCE AND YOGA ARE BOTH POPULAR ACTIVITIES THAT HAVE BEEN SHOWN TO PROVIDE SIGNIFICANT PSYCHOLOGICAL AND PAIN-RELATED BENEFITS WITH MINIMAL RISK. THE ACTIVITIES COMPLEMENT EACH OTHER, IN THAT DANCE INVOLVES DYNAMIC, RHYTHMIC PHYSICAL ACTIVITY, WHILE YOGA ENHANCES RELAXATION AND FOCUS. OBJECTIVE: THIS STUDY AIMS TO EVALUATE THE EFFECTS OF A DANCE AND YOGA INTERVENTION AMONG GIRLS AGED 9 TO 13 YEARS WITH FAPDS. METHODS: THE STUDY IS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AMONG GIRLS AGED 9 TO 13 YEARS WITH FUNCTIONAL ABDOMINAL PAIN, IRRITABLE BOWEL SYNDROME, OR BOTH. THE TARGET SAMPLE SIZE WAS 150 GIRLS RANDOMIZED INTO 2 ARMS: AN INTERVENTION ARM THAT RECEIVES DANCE AND YOGA SESSIONS TWICE WEEKLY FOR 8 MONTHS AND A CONTROL ARM THAT RECEIVES STANDARD CARE. OUTCOMES WILL BE MEASURED AT BASELINE AND AFTER 4, 8, 12, AND 24 MONTHS, AND LONG-TERM FOLLOW-UP WILL BE CONDUCTED 5 YEARS FROM BASELINE. QUESTIONNAIRES, INTERVIEWS, AND BIOMARKER MEASURES, SUCH AS CORTISOL IN SALIVA AND FECAL MICROBIOTA, WILL BE USED. THE PRIMARY OUTCOME IS THE PROPORTION OF GIRLS IN EACH GROUP WITH REDUCED PAIN, AS MEASURED BY THE FACES PAIN SCALE-REVISED IN A PAIN DIARY, IMMEDIATELY AFTER THE INTERVENTION. SECONDARY OUTCOMES ARE GASTROINTESTINAL SYMPTOMS, GENERAL HEALTH, MENTAL HEALTH, STRESS, AND PHYSICAL ACTIVITY. THE STUDY ALSO INCLUDES QUALITATIVE EVALUATIONS AND HEALTH ECONOMIC ANALYSES. THIS STUDY WAS APPROVED BY THE REGIONAL ETHICAL REVIEW BOARD IN UPPSALA (NO. 2016/082 1-2). RESULTS: DATA COLLECTION BEGAN IN OCTOBER 2016. THE INTERVENTION HAS BEEN PERFORMED IN 3 PERIODS FROM 2016 THROUGH 2019. THE FINAL 5-YEAR FOLLOW-UP IS ANTICIPATED TO BE COMPLETED BY FALL 2023. CONCLUSIONS: COST-EFFECTIVE AND EASILY ACCESSIBLE INTERVENTIONS ARE WARRANTED TO REDUCE THE NEGATIVE CONSEQUENCES ARISING FROM FAPDS IN YOUNG GIRLS. PHYSICAL ACTIVITY IS AN EFFECTIVE STRATEGY, BUT INTERVENTION STUDIES ARE NEEDED TO BETTER UNDERSTAND WHAT TYPES OF ACTIVITIES FACILITATE REGULAR PARTICIPATION IN THIS TARGET GROUP. THE JUST IN TIME (TRY, IDENTIFY, MOVE, AND ENJOY) STUDY WILL PROVIDE INSIGHTS REGARDING THE EFFECTIVENESS OF DANCE AND YOGA AND IS ANTICIPATED TO CONTRIBUTE TO THE CHALLENGING WORK OF REDUCING THE BURDEN OF FAPDS FOR YOUNG GIRLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV (NCT02920268); HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02920268. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19748. 2020